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3. PROCESS
3.1 Protocol development
3.2 Trial documentation
3.3 Assessing site suitability
3.4 Application to regulatory approval
3.5 Start-up procedures
3.6 Ethics approval submission
3.7 Site initiation
3.8 Trial materials
3.9 Trial treatment
3.10 Data
3.11 Monitoring and audit
3.12 Termination of study
3.13 Publication plan
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